Pharma giant Sanofi charged in misuse of epilepsy drug
PARIS - Anadolu Agency
Sanofi, one of France's largest pharmaceutical companies, is being charged by French prosecutors for its failure to fully inform the public and causing harm with its epilepsy drug Depakine.
The drug has been linked to birth defects when taken during pregnancy, and involves potentially tens of thousands of victims. More than 100 mortalities have occurred as a result of patients having ingested Depakine.
The drug, also known under the trade names Depakote, Epilim, and Stavzor, is prescribed in over 100 countries to treat epilepsy.
The charges -- aggravated fraud and unintentionally causing injury -- come after a three-year probe launched in September 2016 by victims and their families into the drug, specifically its active molecule, valproate, which has been linked to infant diseases and abnormalities.
Among the reported dangerous side effects are an increased risk of autism and learning disorders, by up to 40 percent, as well as malformations present at birth, by up to 10 percent, studies have shown.
In a statement, the company said it will fully cooperate with prosecutors "to prove it has always complied with its duty to inform and been transparent".
It added that the investigation will afford "the occasion to demonstrate that it respected its obligation to inform" the patients about the drug.
Sodium valproate has been on the market since 1967, utilized as a treatment for both epilepsy and bipolar disorder.
France's health safety agency, ANSM, has long criticized Depakine's risks, estimating serious congenital malformation at 2,150 to 4,100 cases since 1967. The estimate of those affected is as high as 14,000 with the inclusion of neurological deficiencies.
The issue of fetal malformation has been one the company has known about since the 1980s.
Despite prosecutors deciding to move forward with the charges, it remains to be seen whether the case will go to trial.
Sanofi's latest available income statement -- 2018 figures -- shows the company revenue at €34.46 billion.